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The purpose of this study is to investigate whether perioperative single-dose administration of ketorolac (Toradol) can reduce post-operative pain after breast surgery, thereby decreasing post-operative opioid use.
The investigators will perform a double blinded, prospective randomized trial of perioperative ketorolac (Toradol) on breast reduction and breast reconstruction procedures. Patients will be randomized into three groups: group 1 will receive a perioperative dose of ketorolac (Toradol, 15mg), group 2 will receive ketorolac (Toradol, 30mg), and group 3 will be the control and receive a placebo of saline. Patients will be asked to complete a diary or log of their average pain and pain medication use to be turned in at a 2 week follow up visit.
The patients, surgeons, anesthesiologist will not know whether the patient received ketorolac (Toradol) intraoperatively. Patients' pain will be assessed using pain scores in the immediate post-operative period, on post-operative day 1, and at their two-week follow up appointment. If patients leave the same day then they will only have two pain score assessments; on day of surgery and at their two-week follow up. Additionally, patients will be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being extreme pain) in morning and evenings using a patient diary for the two week post-op period. The patient's opioid use will be measured by their opioid use during their hospital stay, as well as how many prescription narcotic pills the patient used to manage their pain at home, as documented using the patient diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Saline injection administered during surgical procedure |
|
| Low Dose (15mg) Toradol | Experimental | 15mg ketorolac (toradol) administered during surgery |
|
| High Dose (30mg) Toradol | Experimental | 30mg ketorolac (toradol) administered during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine | Drug | nonsteroidal anti-inflammatory drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of post-operative pain: Likert scale | This will be assessed by using a Likert scale(0=no pain to 10=extreme pain) for pain in the post-operative period before they are discharged. If patients are kept overnight then another pain assessment will be done. Additionally, patients will keep a 2-week diary of average pain in the morning and evening each day until their 2 week follow up visit. | 2 week post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Change of narcotic use | This will be assessed by calculating the Medial Morphine Equivalent (MME) in the post-operative period. This will include narcotics given while in the hospital and narcotics prescribed and used at home in the patient diary. Perioperative narcotic use will also be recorded. | 2 weeks post operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Thompson | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James T. Thompson | Roanoke | Virginia | 24016 | United States |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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randomized
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double blind randomized trial
| Saline | Other | saline fluid injection |
|
| Complication assessment |
Assess complications including, but not limited to, hematomas, GI issues (nausea, diarrhea, indigestion, heartburn), and headaches. This will be assessed by tracking any readmissions for hematoma evacuation or other complications reported at their post-op follow up visit. |
| 2 weeks to 90 days post operation |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |